Press Room

Continuous Manufacturing of Oral Solid Dosage Forms

Start
Tuesday, April 16, 2024
End
Thursday, April 18, 2024
Location: Portugal
Continuous Manufacturing of Oral Solid Dosage Forms_Hovione

Continuous manufacturing holds the promise of improved efficiency, enhanced quality, greater operational flexibility and accelerated development. At Hovione we are proud to be at the forefront of this industry transition and excited to join leading individuals from industry, academia and regulatory agencies at the ECA Conference on “Continuous Manufacturing of Oral Solid Dosage Forms”. 

Register today

and take advantage of the unique opportunity to visit Hovione's cutting-edge labs and continuous tableting manufacturing facilities in Lisbon, Portugal 

 

The objective of this event is to share the practical experience and the potential of continuous manufacturing for oral solid dosage forms, also known as Continuous Tableting:

  • Regulatory Requirements
  • Industry Experience
  • Technological Opportunities
  • Latest research

Speakers

  • Selma Celikovic, RCPE
  • Prof Dr Alastair Florence, CMAC
  • Joshua Hanson, Eli Lilly
  • Dr Doug Hausner, Thermofisher Scientific
  • Dr Jim Holman, GEA
  • Dr Adrian Kape, Glatt
  • Dr Sau (Larry) Lee, FDA
  • Prof Dr Jim Litster, University of Sheffield
  • Dr Robert Meyer, MSD
  • Dr José Luís Santos, Hovione
  • Wayne Sinclair, TEVA
  • Jan Verelst, Siemens

More about the Conference, Speakers and Programme

More about Hovione Site Visit:
As part of the conference, registered participants will have a unique opportunity to visit Hovione's cutting-edge labs and manufacturing facilities in Lisbon, where research, development, and manufacturing activities take place.

In the labs, participants will gain access to Particle Engineering facilities, explore some of the most advanced analytical PAT tools, and get a close look at the specialized equipment used in continuous tableting development. They will also have the chance to observe analytical and process development operations in an engaging hands-on workshop, guided by Hovione experts.

During the visit to the manufacturing facilities, participants will witness a state-of-the-art facility in action, showcasing a continuous direct compression production unit. Additionally, they will have the opportunity to see and compare with an equivalent batch process.
Please note that availability for this exclusive site visit is limited, so securing your spot early is highly recommended to ensure you don't miss out on this opportunity to experience Pharmaceutical innovation at Hovione.

  • We provide bus transfer from the conference hotel to the Hovione sites. After the site visit there will be transfers to the airport and back to the conference hotel.
  • Due to competition reasons, individual participants may be excluded from the site visit
  • Participants are required to sign a Confidential Disclosure Agreement (CDA) before entering Hovione sites

More about the ECA Academy:
The ECA Academy is the educational organisation established by the ECA Foundation. It develops and organises a wealth of international education courses, conferences (also as part of a GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc, European conferences are organised as discussion forums on new trends and developments.

If you have any questions about the Conference:
Tel.: +49 (0)6221 / 84 44 0 
www.gmp-compliance.org

 

 

Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024